TOP FINE INSULIN SYRINGE by DAEJIN TECH MEDICAL MANUFACTURING CO., LTD.

Top Fine® insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle . The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.3 ml/cc, 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. Rx only. The devices operate on the principles of common piston syringes.

AI/ML Overview

The provided text describes the 510(k) summary for the "Top Fine® Insulin Syringe" (K063348), comparing it to a predicate device (BD Insulin Syringe K024112). It focuses on demonstrating substantial equivalence rather than presenting detailed acceptance criteria and a specific study proving the device meets them quantitatively in the way one might expect for a complex AI/software device.

However, based on the provided text, I can infer the "acceptance criteria" were related to safety and effectiveness, and the general "study" information is about these aspects.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from text)	Reported Device Performance (Summary from text)
Biocompatibility (Safety)	Results were satisfactory; no concerns over safety and effectiveness.
Mechanical Performance (Effectiveness)	Results were satisfactory; no concerns over safety and effectiveness.
Sterility (Safety)	Results were satisfactory; no concerns over safety and effectiveness (specifically mentioned "sterile fluid path, (EO), non-toxic, and non pyrogenic").
EO Residues (Safety)	Results were satisfactory; no concerns over safety and effectiveness.
Adequacy of Instructions for Use (Effectiveness/Safety)	Results were satisfactory; no concerns over safety and effectiveness.
Range of Patient Population Suitability (Effectiveness/Safety)	Results were satisfactory; no concerns over safety and effectiveness.
Reliability (Effectiveness)	Results were satisfactory; no concerns over safety and effectiveness.
Substantial Equivalence to Predicate Device (Overall)	Tests demonstrated the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "bench and clinical tests were performed," but does not specify the sample sizes for either the bench or clinical tests. The data provenance (country of origin, retrospective/prospective) is also not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For a physical device like an insulin syringe, "ground truth" is typically established through direct measurements, laboratory assays, and user performance observations rather than expert review of data.

4. Adjudication Method for the Test Set

This information is not provided as it's not relevant for this type of device and testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI interpretation devices, not for a physical medical device like an insulin syringe. The "clinical testing" mentioned was likely focused on user experience and function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not applicable to an insulin syringe, which is a physical device, not an algorithm.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" would have been established by standardized laboratory measurement methods and industry standards for biocompatibility, mechanical properties (e.g., fluid delivery accuracy, needle integrity, plunger force), and sterility.

For the clinical tests (focusing on "adequacy of instructions for use, the range of patient population, performance characteristics, and reliability"), the "ground truth" would likely be based on direct observation of use, user feedback, and comparison to predefined performance metrics.

8. The Sample Size for the Training Set

This concept is not applicable as this is a physical medical device, not an AI/software device that would have a "training set."

9. How the Ground Truth for the Training Set Was Established

This concept is not applicable for the same reason as point 8.

Summary

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K063348 page 1 of 1

MAR 0 ] 2007

510(K) Summary Daejin Tech Medical Manufacturing Co., Ltd. 536-70 Kumkwang-Ri KumKwang-Myun, Ansung-Si, Kyunggi-Do, Korea Contact person: Simon Bang, President Tel : 82-31-671-2161 Fax : 82-31-671-2162 Date prepared: October 25, 2006

1. Trade Name: Top Fine® Insulin Syringe Common Name: Insulin syringe Classification Name: Syringe, piston, product code FMF, Regulation: 880.5860 Class of device: Class II.
1. The legally marketed device to which we are claiming equivalence [807.92(a)(3)| : BD Insulin Syringe K024112.
1. Description of device: Top Fine® insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle . The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.3 ml/cc, 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. Rx only. The devices operate on the principles of common piston syringes.
1. Intended use: For the subcutaneous injection of insulin.
1. Technological characteristics: The Top Fine® Insulin Syringes and the predicate devices have identical technological characteristics and perform the same way as common piston syringes. Whereas the predicate syringes are gamma sterilized, these syringes are EO sterilized.
1. Performance: Both bench and clinical tests were performed. Bench testing included biocompatibility, mechanical testing, sterility testing including EO residues. Clinical testing was performed to determine adequacy of instructions for use, the range of patient population, performance characteristics, and reliability. The results were satisfactory and revealed no concerns over safety and effectiveness as compared to predicate devices. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.

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MAR 0 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Daejin Tech Medical Manufacturing Company Limited C/O Mr. Daniel Kamm, P.E. Principal Consultant Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K063348

Trade/Device Name: Top Fine® Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: February 20, 2007 Received: February 23, 2007

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Kamm

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Suser Runne

$\theta$

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K063348

Indications for Use

510(k) Number (if known):

Device Name:_ Top Fine® Insulin Syringe

Indications For Use:

The Top Fine® disposable sterile insulin syringes are intended for subcutaneous injection of insulin.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number. K96374

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).